510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K033248Substantially Equivalent

Hitachi Cb Mercuray Dental Cone-Beam X-Ray System

FUJIFILM Healthcare Americas Corporation, Twinsburg OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K033248 is the FDA 510(k) clearance record for HITACHI CB MERCURAY DENTAL CONE-BEAM X-RAY SYSTEM, a class II device, cleared for Hitachi Medical Systems America, Inc. on under FDA product code MUH (System, X-Ray, Extraoral Source, Digital). FDA records list 394 510(k) clearances for FUJIFILM Healthcare Americas Corporation, from to . As of , FDA records show no recalls naming K033248.

Clearance record

Decision date
Received
(13 days to decision)
Product code
MUH System, X-Ray, Extraoral Source, Digital
Regulation
21 CFR 872.1800
Device class
Class II
Review panel
Dental
Applicant
Hitachi Medical Systems America, Inc. 1959 Summit Commerce Park, Twinsburg OH
510(k) summary
Summary PDF
Third party review
Yes

Clearances, product code MUH

Trailing 12 months
2 clearances under product code MUH in the twelve months to November 2026, March 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code MUH, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20261
April 20260
May 20260
June 20260
July 20260
August 20260
September 20261
October 20260
November 20260